FDA OKs Protalix's Treatment Protocol Drug For Gaucher Disease

   DOW JONES NEWSWIRES 
 

Protalix BioTherapeutics Inc.'s (PLX) treatment protocol of its lead drug candidate for patients with Gaucher disease was approved by the U.S. Food and Drug Administration, amid an expected shortage of Genzyme Corp.'s (GENZ) Cerezyme.

The FDA last month had requested that Protalix consider submitting a treatment protocol of the drug to treat patients with the life-threatening disease because a Genzyme plant that produces Cerezyme was shut down in the latest manufacturing problem at the Massachusetts facility.

Gaucher disease is a rare, inherited disorder in which an enzyme problem results in harmful quantities of certain fats, especially within the bone marrow, spleen and liver.

Protalix last month said it received indications from the FDA that its prGCD development effort "satisfies the regulatory criteria required to supply prGCD for expanded access to patients under a treatment protocol."

The company said Monday it would provide the drug free of charge to patients enrolled in the protocol, under which physicians and other care-providers can treat Gaucher's patients with prGCD while late stage trials continue and until the treatment's anticipated marketing approval from the FDA.

Protalix expects to complete the study next month and unveil results in October. The company expects to file a new drug application by the end of the year. Cerezyme, which treats Gaucher disease, is Genzyme's biggest revenue producer, with sales of $1.2 billion last year.

Protalix shares closed at $5.77 on Friday and didn't trade premarket.

-By Tess Stynes, Dow Jones Newswires; 212-416-2481; [e-mail]